Toripalimab filed with EU for nasopharyngeal carcinoma
Shanghai Junshi Biosciences has submitted a marketing authorization application to the European Medicines Agency for toripalimab
The indication requested in the MAA is for toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma.
The MAA submission for NPC is based on the results from JUPITER-02 (an international randomized, placebo-controlled, double-blinded Phase III trial, NCT03581786) and POLARIS-02 (a multi-center, open label, pivotal Phase II clinical trial, NCT02915432). The JUPITER-02 results were first presented in June 2021 in a plenary session of the American Society of Clinical Oncology annual meeting (#LBA2) and subsequently published in detail as the cover article of the September 2021 issue of Nature Medicine. The POLARIS-02 results were published online in January 2021 in the Journal of Clinical Oncology.
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